Unintentional pregnancies occur for any number of reasons. Certainly, they can occur following sexual intercourse when neither party uses a contraceptive device or drug. However, this is by no means, the only reason for unintended pregnancies. Condoms are known to break; diaphragms to slip; and traditional contraceptive pills are, by their own admission, not 100 percent effective, even when taken properly. Moreover, when pills are missed, particularly with the newer, low-dose products, the risk of pregnancy increases substantially. In fact, each year in the U.S. alone, approximately 750,000 pregnancies occur to women using traditional oral contraceptive regimens. Of course, some of these pregnancies occur because the patient has failed to completely and dogmatically follow the prescribed pharmaceutical regimen.
In some countries, particularly Europe, emergency contraceptive ("EC") pills are an available treatment for women who are concerned they may have become pregnant by their most recent unprotected sexual encounter. These pills are intended for administration within days, and preferably within hours after unprotected sex and often contain relatively high doses of for example, a progestin and/or an estrogen. Reports in the scientific literature describe other drugs which may be effective for emergency contraception as well. Dosages and protocols will vary with the drug(s) used. However, in each case, the "pills" help to prevent pregnancy, i.e. either preventing a fertilized ovum from implanting in the lining of the uterus and/or depending on the timing of intercourse, preventing the sperm from fertilizing an egg.
Doctors in countries that allow the use of the EC pill will often ask patients when their last period occurred during an office visit. Unfortunately, there are at least two significant drawbacks to this approach. First, a woman may or may not have an accurate recollection of when her last menstrual period occurred. Furthermore, a woman can have a period and still be pregnant. Second, EC pills are not always dispensed by doctors for immediate use. To increase compliance and to provide a higher rate of efficacy, doctors may provide EC pills to their patients well in advance of a sexual encounter. As a result, these pills may sit in a purse or medicine cabinet for weeks or even months before use. In the United States, there is currently no FDA approved version of EC pills. However, gynecologists, obstetricians and other licensed family planning professionals may create their equivalents out of multiple doses from a package of 21 traditional birth control pills, verbally instructing their patients to take a certain number of pills, in the future, if necessary, following unprotected sex. In either instance, this allows the patient to receive treatment even when a doctor is unavailable. Of course, this also removes all possible safeguards which should be employed before any type of medical treatment is undertaken.
Another common problem associated with EC pills is the incidence of nausea which occurs in a significant percentage of patients. Some patients experience vomiting after taking the EC pill. This is not only uncomfortable, but may also compromise the efficacy of the contraceptive. Unless steps are taken to prevent the loss of bioavailable drug from the digestive tract and/or proper medical instruction is given as to how to react in such cases, there is a greater chance of pregnancy. Certainly, a woman who has taken an EC pill and has had an adverse effect, is less likely to take the steps to assure efficacy, including taking more EC pills.
In addition to the problems previously discussed, other problems with the use of EC pills include the possibility that a woman is indeed already pregnant when she takes an EC pill. Oral contraceptive formulations, such as one made from combinations of estrogen and progestin, used postcoitally, will not cause an abortion of that pregnancy, i.e., will not terminate pregnancy if the fertilized ovum has already implanted within the lining of the uterus. A woman in such a position, however, after taking an EC pill, may believe that she has successfully avoided pregnancy and delay seeking immediate and proper medical attention for her condition. The same woman may then commence activities, or return to her normal routine of taking daily contraceptive pills, as well as other prescribed and over-the-counter medicines, or may consume alcohol, commence recreational drug use or undertake other activities which might be detrimental to her pregnancy, without first seeking the appropriate medical care. Many of these activities may cause problems to the pregnancy, and may affect the health or well-being of any child born from that pregnancy. It is always essential that a woman receive appropriate medical care and counseling once a pregnancy is discovered and before continuing with various medications and activities.
Therefore, there remains a need for an easy and convenient way to insure that the taking of an EC pill will be effective in preventing a pregnancy. There is also a great need for an easy, convenient, cost-effective and efficacious way to advise women to seek medical care prior to taking an EC pill, continuing on their normal contraceptive regimen, taking any other medication, or engaging in activity which should be discussed with a medical professional, when indeed she is pregnant.